Understanding the Requirements of ISO 13485:2016 and International MDSAP Audit Model

Understanding the Requirements of ISO 13485:2016 and International MDSAP Audit Model

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Note:Pricing is dependent on location and may vary.

Course Duration: 2 Days - 8 Hours/day

OMNEX is now offering QMS Training based on both ISO 13485:2016 and international Medical Device Single Audit Program (MDSAP) requirements. The two-day training program focuses on international MDSAP and ISO 13485-compliant medical device requirements.

Medical device auditing requires technical knowledge as well as a deep understanding of international medical device regulations. Students participating in this course will gain knowledge and skills to implement a QMS with ISO13485:2016 management system requirements in accordance with the new MDSAP Audit Model.

OMNEX’s Understanding MDSAP training course will teach students to plan, develop and implement a QMS in accordance with MDSAP and ISO 13485:2016 requirements.

Considering the ISO 13485:2016 management system requirements and various regulatory authorities’ compliance requirements around the world and the global supply chains involved, a comprehensive program like OMNEX’s Understanding MDSAP Training is incredibly valuable. The course provides extensive practical training and hand-on exercises, which will help prepare medical device implementers to identify critical MDSAP requirements and set up a QMS to meet international regulatory requirements.

The course is designed for medical device professionals with responsibility for implementing, maintaining and preparing the QMS internal, supplier or corporate management systems. Quality directors, regulatory managers and professionals responsible for managing internal, corporate, supply chain or certification responsibilities may also benefit from this unique training.

Upon completion the participants will be capable to effectively develop, implement and support a QMS to maintain compliance to ISO 13485 and jurisdiction requirements in the countries participating in the MDSAP program.

Participants of the training will learn from highly experienced instructors with decades of experience in medical device quality management systems.

This course will help you:

  • Improve understanding of regulatory auditing
  • Improve competence for MDSAP development, implementation, and maintenance of a QMS that meets all MDSAP audit requirements.
  • Assess your own audit models and suggest an improvement
  • Be prepared to support an efficient MDSAP audit by your selected Auditing Organization

Participants will gain the knowledge and skills to:

  • Demonstrate awareness of MDSAP fundamentals
  • Explain the structure and scope of the MDSAP audit
  • Understand MDSAP and regulatory compliance
  • Understand MDSAP reporting and nonconformity grading methods
  • Determine MDSAP documentation requirements
  • Understand the seven MDSAP auditing process requirements
  • Analyze data sources and control interactions required during process audits
  • Use correct jurisdictional terminology

Day One

  • Introduction and Welcome
  • Chapter 1: MDSAP Background
  • Chapter 2:MDSAP Audit Structure
  • Chapter 3: Quality Management System
  • Written Exercise 1: Risk Management
  • Chapter 4:MDSAP Audit Model and Tasks
  • Management Processes
  • Device Marketing Authorization and Facility Registration
  • Measurement, Analysis and Improvement
  • Written Exercise 2a: Audit Scenarios

Day Two

  • Chapter 4: MDSAP Audit Model and Tasks (cont’d)
  • Medical Device Adverse Events & Advisory Notices Reporting
  • Design and Development
  • Production and Service Controls
  • Purchasing
  • Written Exercise 2b: Audit Scenarios
  • Understanding MDSAP Final Exam

Quality Assurance and Regulatory Affairs professionals within medical device organizations currently active in participating jurisdictions and organizations expanding their market reach to jurisdictions participating in MDSAP.


Thorough understanding of ISO 13485:2016 with experience in auditing ISO 13485:2016 QMS.

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